Storage and dispensing devices for administration of oral transmucosal dosage forms

Abstract

Dispensing devices and systems for oral transmucosal administration of small volume drug dosage forms to the oral mucosa are provided. The dispensing device may be a single dose applicator (SDA), or an electromechanical device comprising a means for patient identification such as a wrist worn RFID tag and annular bidirectional antenna together with a lock-out feature.

It is claimed: 
     
       1. An apparatus, comprising:
 a housing defining an actuation pathway and a channel in communication with the actuation pathway; 
 a delivery member, at least a portion of the delivery member being disposed within the actuation pathway such that a distal end portion of the delivery member and a distal end portion of the housing define a volume configured to contain a drug-containing tablet, the delivery member configured to move relative to the housing in a distal direction to expel the drug-containing tablet from the volume, the delivery member including a protrusion configured to engage a portion of the housing to limit movement of the delivery member relative to the housing in a proximal direction, the delivery member including an elongate protrusion slidably disposed within the channel, an edge of the elongate protrusion configured to limit movement of the delivery member relative to the housing in the distal direction; and 
 the housing includes a bridge configured to engage the delivery member, at least a portion of the bridge configured to be separated from the housing when the delivery member is moved relative to the housing in the distal direction. 
 
     
     
       2. The apparatus of  claim 1 , wherein a removable safety member is configured to engage the delivery member to prevent movement of the delivery member relative to the housing in the distal direction prior to removal of the safety member. 
     
     
       3. The apparatus of  claim 2 , wherein the distal end portion of the delivery member includes a concave portion. 
     
     
       4. The apparatus of  claim 1 , wherein the distal end portion of the housing is configured to deform when the delivery member is moved in the distal direction relative to the housing to produce an opening through which the drug-containing tablet can be expelled. 
     
     
       5. The apparatus of  claim 1 , wherein:
 the housing includes a first portion and a second portion, the first portion and second portion collectively define the actuation pathway, 
 at least one of the first portion or second portion is configured to flexibly deform. 
 
     
     
       6. The apparatus of  claim 1 , further comprising a drug-containing tablet disposed in the volume, the drug-containing tablet including a dosage of sufentanil. 
     
     
       7. The apparatus of  claim 6 , wherein the drug-containing tablet includes an amount of sufentanil selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg, and wherein said drug-containing tablet has a volume of less than 30 microliters or a mass less than 30 mg. 
     
     
       8. The apparatus of  claim 1 , wherein the housing and delivery member are configured to enable a user to deliver a drug-containing tablet to a sub-lingual mucosal membrane. 
     
     
       9. The apparatus of  claim 1 , wherein the distal end portion of the delivery member includes a sloped surface configured to engage the distal end portion of the housing when the delivery member is moved in the distal direction relative to the housing to deform the distal end portion of the housing to produce the opening. 
     
     
       10. An apparatus, comprising:
 a housing defining an actuation pathway and a channel in communication with the actuation pathway; and 
 a delivery member, at least a portion of the delivery member being disposed within the actuation pathway such that a distal end portion of the delivery member and a distal end portion of the housing define a volume configured to contain a drug-containing tablet, the delivery member configured to move relative to the housing in a distal direction to expel the drug-containing tablet from the volume, the distal end portion of the delivery member configured to engage the distal end portion of the housing when the delivery member is moved in the distal direction relative to the housing to deform the distal end portion of the housing to produce an opening through which the drug-containing tablet can be expelled, the delivery member including a protrusion configured to engage a portion of the housing to limit movement of the delivery member relative to the housing in a proximal direction, the delivery member including an elongate protrusion slidably disposed within the channel, an edge of the elongate protrusion configured to limit movement of the delivery member relative to the housing in the distal direction. 
 
     
     
       11. The apparatus of  claim 10 , further comprising a drug-containing tablet disposed in the volume, the drug-containing tablet including a dosage of sufentanil.